Study to Evaluate the Safety and Pharmacokinetics of Inhaled Ciprofloxacin in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT00961038 | Completed Phase 1

• 2 other identifiers: 130142008-006771-79
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives of the study are to investigate the safety, tolerability and levels of ciprofloxacin in the lung after single and multiple inhalative administration to patients with moderate to severe COPD (stage II-III according to GOLD Criteria)

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Ciprofloxacin; Inhalation; Pharmacokinetics; Safety; Tolerability; COPD

Outcome Measures

Primary Outcomes (4)

• Vital signs

  Within 28 days after first treatment

• Electrocardiogram (ECG)

  Within 28 days after first treatment

• Pulmonary function test

  Within 28 days after first treatment

• Pulse-oximetry

  Within 12 days after first treatment

Secondary Outcomes (4)

• Ciprofloxacin concentrations in blood

  Within 14 days after first treatment

• Ciprofloxacin concentrations in urine

  Within 14 days after first treatment

• Ciprofloxacin concentrations in sputum

  Within 14 days after first treatment

• Ciprofloxacin concentrations in mouth fluid

  Within 7 days after first treatment

Study Arms (3)

Arm 1

EXPERIMENTAL

Drug: Ciprofloxacin (PulmoSphere, BAYQ3939)

Arm 2

EXPERIMENTAL

Drug: Ciprofloxacin (PulmoSphere, BAYQ3939)

Arm 3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ciprofloxacin (PulmoSphere, BAYQ3939) DRUG

32.5 mg ciprofloxacin betaine corresponding to 50 mg Ciprofloxacin PulmoSphere inhalation powder will be given as an initial single-dose inhalation (day 0).During the multiple-dose phase (day 2 to day 11), the same dose will be given twice daily, with a concluding single dose (on day 12)

Arm 1

Placebo DRUG

Placebo inhalation powder will be given as an initial single-dose inhalation (day 0).During the multiple-dose phase (day 2 to day 11), placebo will be given twice daily, with a concluding single dose (on day 12)

Arm 3

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with COPD, 40 to 75 years of age
• Diagnosis of COPD
• Airway obstruction with a post-bronchodilator Forced Expiratory Volume (FEV1) of \>/=30% and \</=65% of predicted and a post-bronchodilator FEV1 / Forced Vital Capacity (FVC) of \</=70%
• Current or ex-smokers with a smoking history of more than 10 pack-years
• Patients must be able to produce acceptable induced sputum samples (as defined in the Study Procedure Manual)
• Normal body weight: Body Mass Index (BMI) between 19 and 35 kg/m2

You may not qualify if:

• Significant respiratory disease other than COPD as bronchial asthma, Cystic fibrosis or clinically evident bronchiectasis
• More than one COPD exacerbation within 12 months and within 8 weeks prior to screening
• total blood eosinophil count \>/=600/mm3
• Thoracotomy with pulmonary resection
• Regularly use of daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits
• Hypersensitivity to the investigational drug or to other quinolones and/or to inactive constituents of the inhalation powder
• Hypersensitivity of the bronchial system to inhalation of nebulized drugs or saline solution
• Patients with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies
• Concomitant use of medication which could interfere with the investigational drug. Before study drug administration a wash out period of more than 5 half lives has to be considered
• Concomitant inhalative therapy with antibiotics and/or concomitant systemic therapy with
• fluoroquinolones
• Oral beta-andrenergics, beta blockers
• oral steroids
• Methylxanthines: 24-hour washout of short-acting theophylline and 48-hour washout of long-acting theophylline prior to pre-study examination
• Antihistamines, antileukotrienes prescribed for asthma

Sponsors & Collaborators

• Bayer: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Unknown Facility

Hanover, Lower Saxony, 30625, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2009
• First Posted: August 18, 2009
• Study Start: August 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: April 1, 2014

Record last verified: 2014-03

Locations

DE (1)